Kornimate/medical-research-clean huggingface dataset:
comparison of two etanercept regimens (reumatocept® versus enbrel®) for treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is a comparison of safety and efficacy of two etanercept regimens (reumatocept® versus enbrel®) for treatment of rheumatoid arthritis.

study design: • double blinded, non-inferiority, prospective parallel-group, intend to treat trial. study design: * experiment duration: 30 weeks * 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210) * health assessment questionnaire (haq) evaluation * disease activity score (das28) evaluation * clinical disease activity index (cdai) evaluation * american college of rheumatology criteria (acr) evaluation * visual activity schedule(vas) evaluation * adverse events evaluation

Eligibility criteria:
inclusion criteria: 1. patients must be able to understand the study procedures agree to participate and give written consent. 2. patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to american college of rheumatology (acr) criteria; 3. patients with at least 6 swollen joints 4. patients with partial response in treatment with methotrexate for 2 months exclusion criteria: 1. pregnancy and lactation 2. patients with uncontrolled hypertension 3. patients with other rheumatic disease such as sjogren syndrome, systemic lupus erythematosus or spondyloarthritis 4. non-steroidal anti-inflammatory drug in the last 4 weeks 5. any pathology or past medical condition that can interfere with this protocol 6. patients with immunodeficiency and/or immunosuppressive disease; 7. other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
study of retinfanlimab in combination with incagn02385 and incagn02390 as first-line treatment in participants with pd-l1-positive (cps ≥ 1) recurrent/metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus incagn02385 and retifanlimab plus incagn02385 and incagn02390 compared with retifanlimab alone as first-line treatment in pd-l1-positive and systemic therapy-naive recurrent/metastatic (r/m) squamous cell carcinoma of the head and neck (scchn).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed r/m scchn that is not amenable to therapy with curative intent. participants who refuse potentially curative salvage surgery for recurrent disease are ineligible. * eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. * participants must not have received prior systemic therapy for r/m scchn. * pd-l1 positive tumor status defined by cps ≥ 1% per central laboratory determination. * for participants with primary oropharyngeal tumors, documentation of hpv p16 status based on local institutional standard is required. hpv p16 status is not required for other eligible scchn primary tumor sites. * participant must have at least 1 measurable tumor lesion per recist v1.1. * availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy. * ecog performance status of 0 or 1. * willingness to avoid pregnancy or fathering children. exclusion criteria: * progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced scchn. prior pd-(l)1, lag-3, or tim-3 directed therapy, or any other checkpoint inhibitor therapy, for scchn or any other malignancy. * treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment. * presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding. * participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded. * less than 3-month life expectancy. * participant has not recovered to ≤ grade 1 or baseline from residual toxicities of prior therapy. * participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment. * palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is \> 30 gy within 6 months before the first dose of study treatment. * known active cns metastases and/or carcinomatous meningitis. participants will be excluded if it has been \< 4 weeks since radiation therapy was delivered to the cns.

Keywords: squamous cell carcinoma of the head and neck (scchn) incagn02385 incagn02390 retifanlimab igg1κ monoclonal antibody lag-3 tim-3 pd-1 pd-l1
virtual reality and diagnostic of attention deficit hyperactivity disorder (adhd) (pada1)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aim of this study is to develop an application in order to identify the most relevant cognitive and behavioral parameters for the diagnosis of attention deficit hyperactivity disorder (adhd) in conditions closer to reality

attention deficit hyperactivity disorder (adhd) is the most common neurodevelopmental disorder in school-aged children. this disorder is characterized by a symptomatic triad associating, inattention, hyperactivity and impulsivity. cognitive, emotional and behavioral dysfunctions have a strong impact on the school, family and social domains of the child. the clinical diagnosis of adhd is all the more difficult because there are currently no biological, clinical or psychological markers that accurately measure the symptoms of adhd. the diagnosis is made during interviews with specialist doctors allowing the collection of information from parents and the child. virtual reality technology is most recognized as a tool for assessment, rehabilitation of cognitive processes and functional skills. in addition to traditional diagnostic assessment methods, a virtual reality application in an immersive room (cave) in three dimensions could objectively assess the child in a dynamic environment that is as close as possible to everyday situations

Eligibility criteria:
inclusion criteria: group of children with adhd : * children aged 8 to 12 diagnosed with adhd (according to dsm-v criteria) * positive adhd diagnosis with standardized maintenance of kiddie-sads * naïve drug treatment for adhd * schooled in a classic environment * intellectual quotient\> 80 (4 subtests of wasi, or wisc iv-r / wisc-v less than 2 years old) * having french as mother tongue * children benefiting from a social security scheme * signing of free, informed and written consent by the child and the holders of parental authority group of children controls children aged 8 to 12 years undiagnosed adhd (according to dsm-v criteria) : * not presenting with adhd at standardized maintenance kiddie-sads * schooled in a classic environment * intellectual quotient\> 80 (4 subtests of wasi) * having french as mother tongue * children benefiting from a social security scheme * signing of free, informed and written consent by the child and the holders of parental authority exclusion criteria: * positive diagnosis with standardized maintenance of kiddie-sads for the following disorders: mood disorders, psychotic disorders, autism spectrum disorders, severe anxiety disorders and severe tic disorders * presenting a hearing or vision diagnosis diagnosed that does not allow the task to be performed in virtual reality * neurological disorders * photosensitive epilepsy (contraindication to immersion in virtual reality) * treatment with psychostimulants or other psychotropic drugs * unable to complete the virtual reality task during the familiarization session

Keywords: attention deficit hyperactivity disorder virtual reality
non-invasive pressure monitor for neonates & infants at risk of developing hydrocephalus

Conditions: Hydrocephalus in Infants

Summary: the goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. the main questions it aims to answer are: * can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without * can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.


Eligibility criteria:
inclusion criteria: * being monitored for hydrocephalus, or healthy controls exclusion criteria: * known hypersensitivity to materials used in the contact lens and/or adhesive * open/closed wounds at/near the anterior fontanelle * anterior fontanelle is closed * other conditions deemed relevant by the medical team
personalized medicine for diabetes prediction and prevention of complications

Conditions: Metabolic Syndrome; Diabetes

Summary: the metabolic syndrome is a collection of related risk factors that predispose to the development of type 2 diabetes mellitus and cardiovascular disease. the investigators will examine the hypothesis that the metabolic and genomic characteristics of patients with metabolic syndrome and/or diabetes that are at risk for developing complications differ from each other and can be detected using specific biomarkers in blood or in the exhaled breath. early detection of these individuals will enable personalized treatment to prevent and treat diabetes and its complications

breath samples will be collected in inert respiratory bag from diabetic and healthy volunteers, and analyzed using a chamber containing nano-chemical sensors. these samples together with blood samples will additionally be characterized using gas chromatography-mass spectroscopy "gc-ms".

Eligibility criteria:
inclusion criteria: * metabolic syndrome * type 2 diabetes * healthy volunteers with 20\<body mass index\<25 exclusion criteria: * smoking * chronic or acute lung disease
efficacy/safety of valsartan plus amlodipine and valsartan alone in patients with hypertension

Conditions: Hypertension

Summary: this study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * male or female outpatients \>= 18 years and \< 86 years * patients with essential diastolic hypertension * at visit 1, the patient must have mean sitting diastolic blood pressure \>= 95 mmhg and \< 10 mmhg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure \< 100 mmhg * at visit 2, patients must have a mean sitting diastolic blood pressure of \>= 95 mmhg and \< 100 mmhg * at visit 3, patients must have a mean sitting diastolic blood pressure of \>= 90 mmhg and \< 110 mmhg exclusion criteria: * severe hypertension \>= 180/110 mmhg * known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures * inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to visit 2 * history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization * malignant hypertension * all patients with type i diabetes and those patients with type 2 diabetes who are not well controlled based on the investigator's clinical judgment * pregnant or nursing women * history of heart failure * angina pectoris * second or third degree heart block * life threatening or symptomatic arrhythmias * clinically significant valvular heart disease * evidence of a secondary form of hypertension * known or moderate malignant retinopathy * evidence of hepatic disease * evidence of renal impairment other protocol-defined exclusion criteria may apply.

Keywords: hypertension, valsartan, amlodipine, high blood pressure
sleep apnea-hypopnea syndrome (sahs) and ventricular arrhythmias

Conditions: Sleep Apnea; Ventricular Arrythmias; Systolic Left Ventricle Dysfunction

Summary: hypothesis: the cpap treatment diminishes the effect of ventricular arrhythmias in patients with ischemic heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep apnea-hypopnea syndrome (sahs)objectives: to analyze the incidence of ventricular arrhythmias (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable cardioverter-defibrillator (icd) and sleep apnea. to study the effect of cpap on the cardiac arrhythmias and on the number of appropriate defibrillator therapies. design: parallel, randomized and single-blinded multicentric study to compare cpap vs. hygienic-dietetic recommendations. patients with sahs (ahi≥15) and systolic left ventricle dysfunction patients with an icd. duration: 24 months.

secondary objectives: to compare the prevalence of sahs in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with icd with that of the general population. to study the incidence of supraventricular arrhythmias (atrial fibrillation, atrial flutter or supraventricular tachycardia) and inappropriate defibrillator therapies in these patients. to value the effect of the treatment with cpap on the above mentioned arrhythmias. to relate the effect of ventricular and supraventricular arrhythmias with sleep parameters, cardiovascular biomarkers, inflammation and oxidative stress. to evaluate the long-term effect of the cpap on systemic biomarkers in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction. to evaluate the long-term effect of cpap on the quality of life in these patients. sample size: 224 patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with icd will be included to randomize 19 sahs subjects for arm.

Eligibility criteria:
inclusion criteria: * previous diagnostic of ischaemic heart disease of dilated myocardiopathy * ejection fraction of left ventricle \< 40% * patients with implantable cardioverter-defibrillator exclusion criteria: * diurnal hypersomnolence with ees \> 16 * morbid obesity (bmi \> 35 kg/m2). * moderate-severe chronic obstructive pulmonary disease (fev1/fvc \< 70 % and fev1 \< 80 % of reference). * known thyroid disease. * previous treatment with cpap.

Keywords: sleep apnea cpap ventricular arrhythmias defibrillator therapies
thyroid hormone replacement for subclinical hypothyroidism and chronic heart failure (thyroheart-chf)

Conditions: Heart Failure; Subclinical Hypothyroidism

Summary: based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (hf) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with hf and subclinical hypothyroidism. the study is a prospective, randomized, parallel-group trial to assess the efficacy and safety of levothyroxine replacement on evidence-based hf standard therapy in stable chronic heart failure patients with subclinical hypothyroidism.

the primary objective of this trial is to determine whether the 24-week l-t4 replacement therapy, as an adjunct to standard treatment, would improve exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism compared to the standard treatment.

Eligibility criteria:
inclusion criteria: * aged 18 years or older, male or female. * systolic heart failure with new york heart association (nyha) class ii-iii. * left ventricular ejection fraction (lvef) less than 40% by echocardiography during screening and randomization. * sch (tsh: upper limits of normal (uln) -10miu/l, and ft4 level within reference range). * having received standard hf therapy for at least 2 weeks, having reached target dose or max tolerable dose. * provided informed consent. exclusion criteria: * acute heart failure or acute exacerbation of chronic heart failure within the past 2 weeks. * scheduled cardiac resynchronization therapy or heart transplantation. * history of malignant tumor or life expectancy under 12 months. * already on medications that may affect thyroid function (l-t4, carbimazole, propylthiouracil, amiodarone, lithium). * pregnancy and lactation period. * participation in another clinical trial within the past 30 days. * contraindication or intolerance to evidence-based therapy for chf, such as beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. * known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s). * untreated adrenal insufficiency. * untreated pituitary insufficiency. * untreated thyrotoxicosis. * treatment with levothyroxine must not be initiated in patients with acute myocardial infarction, acute myocarditis, or acute pancarditis. * severe renal dysfunction (egfr≤30 ml/min/1.73m2). * significant hepatic impairment (serum gpt \> 120 u/l). * any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.

Keywords: heart failure subclinical hypothyroidism levothyroxine 6-minute walk test
horizontal bone augmentation of alveolar ridge

Conditions: Platelet-rich Fibrin; Bone Substitutes; Atrophic Maxilla; Cone-beam Computed Tomography; Bone Regeneration

Summary: the objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or leukocyte-and-platelet-rich fibrin (l-prf) for horizontal alveolar ridge augmentation. twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration (gbr) treatment. fourteen surgical sites corresponding to group a received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft (bio-oss small®; geistlich ag, wolhusen, switzerland). in group b, fourteen surgical sites were regenerated with deproteinized bovine bone graft (bio-oss small®) associated with l-prf. in both groups, the grafted region was protected by a collagen membrane (bio-gide® compressed; geistlich ag, wolhusen, switzerland) fixed to the buccal and palatal bone plates using titanium pins. cone-beam computed tomography (cbct) scans were performed preoperatively, immediately after the gbr surgical procedure, after 8 months of gbr healing, and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge. at the time of dental implant placement, after an average period of 8 months following the guided bone regeneration procedures, bone biopsies were taken from the grafted area for histological, histomorphometric, and micro-ct analysis. after a period of 6 months, the dental implants were reopened to receive implant-supported prosthetic rehabilitation. implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage. patient pain perception following bone regeneration procedures was assessed using a visual analog scale. all obtained data were statistically analyzed.


Eligibility criteria:
inclusion criteria: * a requirement for the placement of one to four dental implants exclusively in the maxilla; * insufficient horizontal bone remaining for dental implant placement (maximum width of 4mm); * sufficient vertical bone height for subsequent placement of dental implant(s). exclusion criteria: * any contraindication for dental implant placement; * the need for vertical bone augmentation; * inflammatory or autoimmune disease in the oral cavity; * use of immunosuppressants, corticosteroids, or bisphosphonates; * a history of malignancy in the past 5 years; * smokers; * patients reporting excessive alcohol consumption; * decompensated systemic condition; * uncontrolled periodontal disease; * insulin-dependent diabetic patients; * patients with blood-related diseases.
stenting for symptomatic intracranial artery stenosis registry in china

Conditions: Systematic Intracranial Artery Stenosis

Summary: stenting for systematic intracranial artery stenosis is challenged recently, especially for safety. this registry is aimed to explore the safety profile during peri-operation period in stenting procedures for systematic intracranial artery stenosis in chinese population in real world.


Eligibility criteria:
inclusion criteria: * 18-80 year old * medical failure patient with systematic intracranial artery stenosis * more than 3 weeks after most recent ischemic stroke * digital subtraction angiography(dsa) showed ≥70% stenosis in target intracranial artery * imaging test within 1 week showed bad collateral circulation in target vessel area * diseased vessel diameter≥2mm, length \<15mm, distal vessel is normal exclusion criteria: * diffused intracranial stenosis * acute stroke or tia within 3 weeks * pure penetrating branch stenosis showed by cerebral imaging * non-atherosclerosis pathology for the stenosis * intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source * intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation •\>50% stenosis in extracranial carotid artery or vertebral artery in operation side; known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin \<10g/dl，platelet count \<100000 * modified rankin score ≥3 related to target vessel; * inr(international normalized ratio)\>1.5(irreversible），persist hemorrhage risk; life expectancy \< 1year * pregnant or beast-feeding * not suitable for endovascular stenting judged by indication judgement committee

Keywords: stent, systematic intracranial artery stenosis
reach (restore energy, activity can help) lupus study

Conditions: Systemic Lupus Erythematosus; Fatigue

Summary: the goal of this clinical trial is to pilot test the reach peer coaching program for fatigue in people with systemic lupus erythematosus. the main questions it aims to answer are: 1. is the reach program feasible and acceptable to participants? 2. what is the impact of the reach program on fatigue? researchers will compare the reach peer coaching program to the reach mobile health application to see if the reach program works to reduce fatigue. participants will: * use the reach mobile health application to set weekly movement goals and log daily physical activity * meet weekly with their reach peer coach (if they have one) to talk about their movement goals and progress * complete weekly symptom surveys * complete study surveys when they start the program, in the middle of the program, at the end of the program, and 12 weeks after the program ends * participate in an interview to provide feedback on the program


Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus based on 2019 american college of rheumatology classification criteria * ≥ 18 years of age * english-speaking * ownership of a smartphone * physician's permission to participate in the study (including engagement in physical activity) * fatigue severity scale score ≥ 4 exclusion criteria: * inability to consent or comply with the study protocol (cognitively impaired adults).

Keywords: physical activity peer coaching mobile health application chronic disease self-management